argx-117 in deceased donor kidney transplant recipients at risk for delayed graft function

Conditions: Delayed Graft Function

Summary: the main purpose of this study is to evaluate the safety, efficacy and tolerability of argx-117 in deceased donor kidney transplant recipients at risk for delayed graft function. the study consists of 2 parts: part a comprises the main study period, and part b comprises the long-term observational follow-up period. during part a, after the screening period, eligible participants will be randomized to receive either argx-117 or placebo, entering the treatment and evaluation period (duration of up to 52 weeks). after the treatment period, participants will enter a follow-up period of up to 12 weeks. the total study duration varies from approximately 64 weeks up to 5 years post-transplant depending on whether a participant enrols in part b of the study.


Eligibility criteria:
inclusion criteria: * is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years * agree to use contraceptive measures consistent with local regulations * are diagnosed with esrd and have been stable on chronic dialysis for at least 3 months * are recipients of de novo or second-time, single kidney transplant from a deceased donor, either dcd (donation after cardiac/circulatory death) or dbd ( (donation after brain death) * are abo compatible with donor allograft, except for type a2 donor to type b recipient kidneys * have a negative cross match * have received pretransplant vaccinations for: neisseria meningitidis, streptococcus pneumoniae, and haemophilus influenzae, or are willing to receive the vaccinations approximately 3 to 4 months posttransplant exclusion criteria: * any history of prothrombotic disorder or history of thrombosis or hypercoagulable state, excluding vascular access clotting * any known history of complement deficiency * evidence of peritonitis in participants on peritoneal dialysis * received any solid organ, bone marrow, or hematopoietic stem cell transplant, with the exception of prior first kidney transplant * high risk within the study period for recurrence of underlying renal disease in the opinion of the investigator * clinically significant comorbidity, recent major surgery (within 3 months of screening), history of any treatment nonadherence, or intention to have surgery during the study other than kidney transplantation; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk * clinically significant active bacterial, viral, or fungal infection * history of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 5 years or more before first study drug administration. adequately treated participants with the following cancers can be included at any time: basal cell or squamous cell skin cancer; carcinoma in situ of the cervix; carcinoma in situ of the breast; incidental histological finding of prostate cancer * history of current alcohol, drug, or medication abuse as assessed by the investigator * pregnant or lactating state or intention to become pregnant during the study the full list of criteria can be found in the protocol.